510(k) · Cleared
ClearedTriMAX Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crossroads Extemity Systems, LLC · JDR Staple, Fixation, Bone
Cleared on Aug 16, 2019 as substantially equivalent to K181410 (Crossroads Extremity Systems, LLC, 2018) and 3 other predicates after a 149-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Aug 16, 2019
- Review
- 149 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K962616 (1996). 128 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 2 generations backK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- 1 generation backK152072 CrossRoads Screw SystemCrossroads Extremity Systems, LLC · 2015
- This deviceK190722 TriMAX Implant SystemCrossroads Extemity Systems, LLC · 2019
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 2 generations backK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- 1 generation backK152072 CrossRoads Screw SystemCrossroads Extremity Systems, LLC · 2015
- This deviceK190722 TriMAX Implant SystemCrossroads Extemity Systems, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −2 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| −1 | K152072 | CrossRoads Screw System | Crossroads Extremity Systems, LLC | 2015 | — |
| 0 (this device) | K190722 | TriMAX Implant System | Crossroads Extemity Systems, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 8 | 0 |
| 2000 | 9 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 8 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181410 | MotoCLIP/HiMAX Implant SystemSummary page 4…ixation appliances and accessories) Panel: 87- Orthopedic Product Code: JDR Predicate Devices: CrossRoads MotoCLIP™/HiMAX Implant System (K181410) CrossRoads Screw System (K152072) Stealth Staple (K153622 and K163440) Device Des… | 2018 |
| * | K152072 | CrossRoads Screw SystemSummary page 4…87- Orthopedic Product Code: JDR Predicate Devices: CrossRoads MotoCLIP™/HiMAX Implant System (K181410) CrossRoads Screw System (K152072) Stealth Staple (K153622 and K163440) Device Description: The TriMAX™ Implant System is a staple system w… | 2015 |
| * | K153622 | First Ray Internal Bone Staple SystemSummary page 4…redicate Devices: CrossRoads MotoCLIP™/HiMAX Implant System (K181410) CrossRoads Screw System (K152072) Stealth Staple (K153622 and K163440) Device Description: The TriMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation… | 2016 |
| * | K163440 | Stealth Staple SystemSummary page 4…ices: CrossRoads MotoCLIP™/HiMAX Implant System (K181410) CrossRoads Screw System (K152072) Stealth Staple (K153622 and K163440) Device Description: The TriMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the manag… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 27 of the 128 ancestors have a recall of any class.
- 2 other devices also cite its predicate K181410.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The TriMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190722 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190722: TriMAX Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190722
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026